Kyrgyzstan Regulatory Compliance

General Overview

As early as 2019, the Kyrgyz Republic Government issued Decree No. 470/12.09.2019 for the “Product Marking identification in the Kyrgyz Republic” and Decree No. 554/17.10.2019 The procedure for product labelling with digital identification in the Kyrgyz Republic, followed by a pilot project that was conducted. In January 2022 the government published KR-DSM -11/27.01.22 “Approval rules for marking medicinal products and medical devices” of the Minister of Health of the Republic of Kyrgyzstan” and in September 2022, the government published Order No. 1110/09.02.2022 – “Serialization and traceability process of medicines in Kyrgyzstan”, that specifies the track and trace requirements for pharmaceuticals.

By Resolution of the Cabinet of Ministers of the Kyrgyz Republic dated February 9, 2023 No. 53 “Implementation of a drug traceability system in the Kyrgyz Republic”, it was decided to launch a phased introduction of a traceability system for medicines produced, imported and sold in the territory of the Kyrgyz Republic.

The Department of Pharmaceuticals and Medical Devices at the Ministry of Health will be responsible for implementing and maintaining the “Электронная база данных лекарственных средств и медицинских изделий” (ИС ЭБД), the information system that will enable the traceability of pharmaceutical products. All participants in the pharmaceutical market, including manufacturers, importers, sellers, and medical institutions, will be required to register in the system to use the labeling.

Implementation Process

Voluntary serialization implementation waves are planned for:

Until July 1, 2023 – Stage 1

Preparing of guidelines, Introduction of traceability for drugs from the List No. 1, Training of healthcare organizations (turnover participants), Equipment for work in the traceability system, Registration in the ИС ЭБД of a healthcare organization as a participant in the turnover

From July 1, 2023 – November 1, 2023 – Stage 2

Implementation of traceability for drugs from the List No. 2

From November 1, 2023 – March 1, 2024 – Stage 3

Implementation of traceability for medicines included in the traceability system, List No. 3 and not included in Lists No. 1 and No. 2

From March 1, 2024 – June 30, 2024 – Stage 4

Implementation of traceability for all medicinal products in circulation in the territory of the Kyrgyz Republic

Click here to download the most updated medicine list issued by MoH: http://pharm.kg/upload/%D0%BF%D1%80%D0%B8%D0%BA%D0%B0%D0%B762_compressed.pdf

Serialization

The identified types of serialization are Internal marking (into the Kyrgyzstan territory) and external (cross-border for EAEU countries) marking.

External marking: Decree No. 577/08.05.2019

External (cross-border) marking is voluntary for import to the EAEU countries

Internal (mandatory) marking:

Mandatory on the territory of the Kyrgyz Republic.

The circulation of non-labelled products is prohibited according to the current legislation.

Barcode Requirements

2D Data Matrix:

GTIN
Serial Number (SN)
Batch number/LOT
Expiry date

For the Human Readable Part:

GTIN – mandatory;
Serial Number – mandatory;
Batch number/LOT – optional;
Expiry date – optional.

Aggregation

Aggregation is not mandatory.

Aggregation of medicinal products must be performed by requirements of Decision №53/09.02.2023 on the implementation of traceability system for medicines in Kyrgyz Republic. It must be presented by digital number SSCC code and to be applied to the front or side of each individual group package.